Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Symptoms Associated With Menopause

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vasomotor Symptoms Associated With Menopause

Treatments: Drug: Bazedoxifene/Conjugated Estrogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234819

3115A1-305

Details and patient eligibility

About

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.

Sex: Female

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago
• Intact uterus
• Seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week

Exclusion criteria

• History of active presence of thrombophlebitis, thrombosis, thromboembolic disorders
• History of active presence of stroke, TIA, heart attack or ischemic heart disease
• History of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind